Accrediting Agencies

Hi all- I'm trying to find the specific standard regarding sharing of pre-transfusion testing results between hospitals. We all know that if patient receives blood at hopsital "A" and then is transferred to hospital "B" across town, that the Type & Screen and 2nd determination of blood type needs to repeated at hospital "B" before units can be allocated. So, can someone provide the specific CAP and/or AABB standard(s) that would prevent hospital B from using the results from hospital A? In case you're wondering! We're in a situation where the blood bank at our hospital has been doing pre-transfusion testing and supply of blood products to a stand-alone ED located abo…

We are in the process of validating the new automation in our blood bank. Is there anyone who can share validation plan for ortho vision max.we need some ideas how to go about it. Many thanks

During a recent CAP inspection, my facility was cited for not having an annual competency assessment performed for the Blood Bank supervisor (me). Our lab director completes an assessment each year stating that each supervisor is competent to oversee their respective department(s) and listing specific supervisory tasks that are assessed. Shouldn't this supervisor assessment also be sufficient to verify that I am competent to perform testing in the Blood Bank? It seems a bit silly to me that I am deemed competent to assess the competency of the rest of my staff, but I'm not competent to perform the same tasks myself. I must have one of my staff observe me performing cr…

I just recently took over as the Blood Bank Lead/Supervisor and have been contemplating getting an AABB individual membership. My facility won’t pay for it unfortunately, so before I spend $170 I want to see if it’s worth it. We are only CLIA certified and not accredited by any agency, but I would like for us to follow AABB standards (or CAP, etc.). We have copies of the standards and technical manual but I would like to find good resources for improving our procedures and practices. My first project is to require ABO confirmations before giving type specific RBCs. I was also curious about the mentorship program and what that would offer. Any advice would be greatly appre…

Hello, We have an off-site clinic that is planning on providing therapeutic PRP joint injections using the patient's own blood. Are there any AABB/CAP rules or regulations around this service? Does Transfusion Service need to have policies in place if this is being performed off-site in a physician office? Thanks!

For the AABB BBTS 34th addition, has anyone been able to implement any Risk Assessment policies or forms that they would be willing to share?

We have in our blood administration policy that transfusion is given at a slow rate for the 1st 15 mins and then can be increased; we do not state this is documented. An inspector asked us for documentation to prove the rates we are using during a transfusion. We do not have a way to document this, does anyone document their infusion rates and changes to during the transfusion? The are citing PC.2.01.01 that blood transfusions are administered according to state laws and approved policies.

We are about to become the blood bank (and laboratory) for another hospital that is being built across the street from us, but is not part of our "system." Because of this we are going to register with the FDA. The other hospital will be storing a few O negative packed cells from us in an under counter refrigerator in their ER. My question is: When we get inspected, will the FDA need to go see their refrigerator? The reason I ask is that I am beginning the process of registration, but don't want to do it too early and have an inspection before the other hospital is open for business. Do I wait until closer to their opening to submit my application, or will the FDA likely …

Does anyone use these together? With CAP and other agencies you can get an excel file of standards to upload into inspectionproof. MediaLab says the support JC standards but we can't get those in excel format. Any advise?

The checklist says "If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for comparability of results". I had interpreted this requirement applies to routine blood group and Rh test and antibody screen only. It should not apply to antibody identification methodologies because different methodologies can be used to identify the antibody depending on the characteristics of the specific antibody. But now there is opinion saying that this also applies to the antibody identification testing. Please share your thoughts on this, particularly if you are t CAP …

How are others handling CAP TRM43850 "Are methods adequate to ensure removal of almost all of the plasma when washing RBC's?" Dip stick for protien?

Our blood is shipped to us from Omaha and St. Paul (ARC), and sometimes arrives to Denver later than the transport boxes are validated for, which is 48 hours. These units are frequently still in the acceptable transport temp range, be they platelet or red cells. Historically, we have tossed these units since they did not arrive to us within the validated time frame, but I am looking for a way to stop doing that. The FDA publishes exceptions to 21CFR640, which are publicly available, and has many exceptions listed where they have allowed the use and distribution of products when they were stored outside of the required temperature ranges for a specified amount of tim…

Rewriting a blood bank specific LIS policy for AABB compliance. Would anyone have an example they'd be willing to share? There's so many non-Lab pieces to this requirement (3.9) that I'm afraid something will fall through the cracks.

We have an upcoming CAP inspection for all Lab sections and today we have received a big list of documents, Policies and Procedures etc, that one of the inspectors wants us to send them in advance. This is the first time we have experienced this with CAP especially as its an onsite, not remote inspection. Thoughts on this?

In our part of the world we are unable to purchase any commercially available Kleihauer reagents/kits, we have started making our own from the base chemicals following the method described in the AABB test method guide. I'm assuming this would constitute a LDT under CAP? in this case for validation and QC purposes what would we have to do in addition to the usual test method validation and QC's with every batch? if anything. Just to clarify, we are making up the Citrate phosphate buffer and the Eosin solution, the Hematoxylin is a commercially supplied. TIA

Had a CAP inspector cite for not performing a visual inspection at "issuance" from a Blood Track Emerge remote refrigerator. For those of you with a Blood Track Emerge or Haemobank, how are you documenting visual inspection at issuance (the removal from the refrigerator)? She stated that even though the unit is visually inspected at the bedside prior to transfusion, this does not meet the requirement of VI at issuance as the unit can be in the remote refrigerator for several days.

Does any have this or has had it in the past? Do you find it helpful? My currently facility doesn't really have a formal committee for this and trying to start one. Wondering if these guidelines would be a good place to start as far as topics discussed and goals.

Is anyone aware of a rule that requires the location of your facility to be on an SOP? I am not referring to a patient report where I need to include the location of the lab, the lab director, and the CLIA number. These are internal SOPs. Thank you

Has anyone taken the George Washington University online SBB review course? Would love to hear pros and cons...Did you pass the exam after completing the course? thank you

There's been a debate over dropping CAP accreditation after the VA did it. Has anyone done this? Please share any pros/cons you experienced. Right now we can only speculate. That would leave us with Joint Commission, CLIA/FDA, and AABB.

I received the following e-mail from a colleague of mine. It may be useful. Dear all I don't know if you have seen the EUBIS- Europe website. Please have a look there is a lot of interesting information on this site. http://www.eubis-europe.eu/index.php ·Revised MHRA Inspection Manuals ·Common Criteria for the Inspection of Blood Establishments ·Audit/ Inspection Training Guide ·Blood-SOP Manual Well a bit of light reading for the weekend for all who expect MHRA inspections. Kind regards and a lovely weekend Erika :):)

Can any one post electronic copy of CSTM standard here or willing to send it to my e-mail address?

Has anyone out there done this records request inspection from the FDA? Curious how you provided the information and what your experience was if you are willing to share.

Does anyone have online competency forms (word or excel preferably) that went through CAP inspection without deficiencies they would be willing to send me? I'm specifically looking for something easy to use that's not more than a couple of pages. Our last CAP we as a lab got hit again, not that are staff aren't competent but because our paperwork was not consistent between departments. Now we started using a packet that contains 6 different forms: Competency Summary Form (one for each patient test method), Patient Testing Direct Observation Checklist (one for each test method), Instrument maintenance Direct Observation Checklist (one for each piece of equipment used i…

Is there any standard that states blood should be started within 30 minutes from time of issue? We have that statement in our Nursing transfusion procedure but since the 30 minute return time is no longer in place we want the unit to be used after 30 minutes if it is delayed due to IV problems, etc. as long as it can be completed within 4 hours. Nursing does not want to use if it is past the 30 minute timeframe.